EP0173723A1 - Prosthesis for replacing aortic valves. - Google Patents
Prosthesis for replacing aortic valves.Info
- Publication number
- EP0173723A1 EP0173723A1 EP85901357A EP85901357A EP0173723A1 EP 0173723 A1 EP0173723 A1 EP 0173723A1 EP 85901357 A EP85901357 A EP 85901357A EP 85901357 A EP85901357 A EP 85901357A EP 0173723 A1 EP0173723 A1 EP 0173723A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- wing
- prosthesis according
- prosthesis
- ring body
- swivel
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2403—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with pivoting rigid closure members
Definitions
- the aortic valves represent one of the four heart valve systems working as "non-return valves". They are located between the left ventricle and the entrance space of the aorta and have the shape of three semi-ellipsoid pockets which are open towards the aorta and whose aortic corners meet in a triangle .
- these pockets attach themselves to the aortic wall during contraction of the left ventricle (systole) and thus enable the blood flow from the left ventricle to flow freely into the aorta, while they subsequently relax "in the left ventricle (diastole ) fill with blood from the aorta and thereby put them together so that no slide stolen blood from the aorta can flow back into the heart chamber.
- Malfunctions in the aortic valve area be it a defective closing ability of the valves (insufficiency) or an inability to open them completely (stenosis), in many cases necessitate an operative intervention with which the defective valves can be replaced by an implanted aortic valve. Prosthesis to be replaced.
- This prosthesis is to be regarded as a check valve that mimics the function of the aortic valves and in principle consists of a valve seat in the form of a rigid ring body, which can be suturized with the aortic wall by means of a textile hem arranged on the outside, and an associated closing part, each after the cardiac rhythm phase (systole or diastole) the passage through the inner opening of the ring body opens or blocks.
- the ring body is a short cylindrical piece which is sewn to the heart muscle tissue in the area of the so-called “aortic valve ring" (a level just below the lower ends of the three valve pockets on the side of the heart) and the closing part has the shape of a valve ball held in a cage or is a wing closure which is designed either as a swivel wing closure or as a folding wing closure.
- a flat circular disk covering the passage of the cylinder piece and essentially circular, which can be swiveled about a swivel axis running somewhat eccentrically of the disk, is mounted in the cylinder piece in such a way that when the larger disk part opens to the aorta there and • Swing the smaller part of the disc into the heart chamber.
- two flat, essentially semicircular folding wings are provided, each covering half the passage of the cylinder piece and supported on their straight edges with two parallel, closely adjacent pivot axes in the cylinder piece in such a way that they face one another can open in the entrance space of the aorta.
- the prosthesis with wing closure has generally proven somewhat better than those with ball closure and is therefore currently preferred in practice.
- they still have a number of shortcomings that adversely affect their function.
- the outer wing ends move tangentially to the aortic wall when opening and closing, which gives rise to the risk that the wings can be prevented from opening completely by abnormally protruding wall parts.
- the wings also have inadequate flow dynamics, so that zones with slowed to still blood flow can form in the wing area, which lead to the deposition of blood clots and thus to the risk of thrombosis.
- the implantation of a cylinder piece in the area of the aortic valve ring is fundamentally unfavorable from an anatomical point of view.
- the left ventricle does not have a circular cross-section at this point, and moreover the aortic valve ring does not correspond to the actual seat of the natural aortic valve, but is an arbitrarily selected, morphologically not delimited area of the ventricular muscles. This interferes the cylinder piece with the muscles and narrows the outflow tract of the heart chamber.
- the invention is based on the consideration that one can not, 'as has happened so far, may restrict be ⁇ on the acquisition of common in fluid mechanics constructions in the heart to be implanted check valve, but must be based on the anatomical units Ge sacrifice ⁇ . According to the invention, the same replacement valve is therefore not used for all heart valve positions, mainly aortic and mitral valve, as before, rather a heart valve is proposed specifically only for aortic valve replacement.
- a non-circular ring body is therefore provided in the prosthesis according to the invention, the three oblique arch sections of which approximately follow the arch-shaped attachment zones in which the natural aortic valves pass into the aortic wall, and their outline is similar to that in nature is approximated to a triangle. Accordingly, three pivoting wings are also available, which log the natural aortic valves move in the direction perpendicular to the aortic wall and in the blocking position give three sealing lines converging in a star shape.
- the prosthesis according to the invention can be implanted above the so-called aortic valve ring in the plane of the natural aortic valves, which means that it can be kept larger than the previous prostheses, which reduces the pressure loss due to the prosthesis. In this level of implantation and in conjunction with its anatomically adapted outline, it does not interfere with the heart muscle tissue.
- the implantation can be carried out more easily and safely, since after the natural aortic valves, which are no longer effective, have been cut out, the ring body can be sewn to the aortic wall without warping and tensioning along the arcuate attachment zones, that is to say to a predetermined structure, as a result of which the dehis - The rate of the seam section can be reduced.
- the prosthesis according to the invention corresponds much better to the physiological requirements than is the case with previous prostheses.
- the wing can be shaped so that all parts of the blood flow evenly around it, thereby avoiding congestion and dead space areas and reducing the tendency to thrombosis.
- the three-leaf construction allows the moving surfaces to be kept smaller than with single or double-leaf flaps, which means that the opening paths and opening times, the torques and the reaction times can be kept smaller, which leads to a reduction in the transvalvular pressure gradient and the blood reflux during the valve closure.
- the opening pressure of the proposed prosthesis is central, as a result of which uniform opening, for example caused by protruding muscle bulges in the outflow tract of the heart chamber, is avoided. Due to the special shape and the movement of the smaller part serving for control, a systolic flushing or washing out of the sinus is achieved, in addition a diastolic sinus vertebra is generated through the recess on the upper side, which in turn leads to a reduced tendency to thrombosis.
- the three-wing concept has the further advantage that the valve load is divided and the risk of joint breaks and premature wear is reduced. In addition, if a wing fails, there is no immediate risk of a fatal outcome, rather there is sufficient time to replace the defective flap, since the two remaining wings still remain functional. Furthermore, the opening process can no longer be hampered by anomalies in the aortic wall, since the pivoting wings no longer move tangentially to the aortic wall.
- FIG. 1 is a perspective view of the prosthesis in open Position
- FIGS. 1-4 shows a modification of the prosthesis according to FIGS. 1-4 when viewed from above in the locked position
- FIG. 7 is a modified version of the pivoting wing in longitudinal section (A) and in a view from the front (B), from the rear (C), from below (D) and from above (E) (partly in section), such as
- the prosthesis shown in its entirety in FIGS. 1 to 4 has a rigid ring body 1, which is composed of three arch sections 2.
- Each arch section 2 is essentially flat and obliquely perpendicular to the center of the imaginary base area defined by the apexes of the arch sections, the arch ends 3 point inwards and the planes of the arc sections 2 enclose an angle of approximately 40-50 °, for example 45 °, with the solder.
- the curvature of the arch sections can be a semicircular arch (as shown in FIGS. 1 to 4), a semi-elliptical arch, a parabolic arch or some other curved arch which largely corresponds to the course of the attachment zones of the natural aortic valve leaflets on the aortic wall.
- a swivel wing 4 is mounted in each arch section 2, the swivel axis 5 of which extends near the arch ends 3 through the swivel wing 4 in such a way that the upper wing part 6 has a larger area than the lower wing part 7. This ensures that the swivel wing 4 due to the given pressure ratio during the systole of the left ventricle opens and assume a stable position according to FIG. 1 or FIG. 3 and that they swivel back quickly and safely into the blocking position at the beginning of the diastole.
- the swivel bearing of the swivel wing can be designed in any manner and consist, for example, of pegs which are inserted from the outside into bores of the ring body 1 and which engage in corresponding recesses in the swivel wing on the inside of the ring body, a bearing construction being able to do so be selected with bearing play, which causes the bearing to be washed out with each swivel operation.
- the curved sections 2 can be provided with connecting sections, the surface of which extend in a plane substantially parallel to the imaginary base area.
- the connecting pieces should be provided with a support surface 24 (recognizable in FIG. 8B) on which the larger wing part 6 rests in the closed state and thus relieves the bearing.
- the connecting piece can be provided with a projection 25 pointing towards the solder, in order to limit the lateral projection of the wing and thus to counter the risk of interference with the wall of the main artery.
- the three arc sections 2 and the three swivel wings 4 are each designed to match, so that the prosthesis has a three-fold rotational symmetry with respect to the solder in the center of the base area of the ring body 1.
- This is the basis of the representation of FIGS. 1 to 4.
- an asymmetrical prosthesis is also possible, in which the inclined position of the arch sections, their shape of curvature and / or the shape and size of the swivel wings are designed differently. This can be expedient in individual cases, for example in order to take anatomical features into account or to make the flow behavior asymmetrical.
- each swivel wing 4 must be shaped so that it covers the associated arch section 2 in the locked position of the swivel wing 4, and the upper wing part 6 of each swivel wing must have two inner edges 8 running at an obtuse angle to one another, along which the pivoting wings can sealingly lie against one another in the locking position.
- the inner edges of the pivoting wings 4 are straight, flat edges which butt in the locked position, in a preferred embodiment the inner edges 8 are spherical. which ensures reliable closing even with slight bearing play.
- the pivot axes 5 are arranged in the region of the outermost ends of the bow ends 3, so that the beginning part of the edge of the upper wing parts 6 has a sealing line 10 with the ring body 1.
- This sealing line 10 can run differently, as the designs according to FIG. 4 show in comparison with FIG. 5.
- the different course of the sealing line 10 has practically no effect on the function of the prosthesis.
- the swivel wings 4 are thin disks (FIG. 6), in which the upper wing part 6 is essentially flat and the lower wing part 7 has a depression which runs transversely to the swivel axis and forms an indentation in the direction of the solder is provided.
- the swivel blades can also be designed as flow bodies and provided with a streamline profile. This possibility is illustrated in FIG. 7.
- the longitudinally extending recess 9 is formed by a corresponding shaping of the wing profile.
- the prosthesis according to the invention is made of pen prostheses are manufactured using the usual materials that have proven their worth.
- the ring body 1 is surrounded by a textile hem 15, which is not particularly shown in FIGS. 1 to 4, but can be seen in FIG. 8.
- the arrangement is expediently such that the inside of the ring body is rounded in a streamlined manner and that it receives the textile hem in a groove 23 on the outside, so that ingrowth of the body's own tissue on the sealing line area of the ring body is avoided.
- FIG. 8A further illustrates a preferred embodiment, in which the cross section of the curved section 2 is triangular in the region of its apex such that the first surface 26 of the curved section 2 is runs essentially parallel to the small wing part 7 when the wing 4 is open, which in this area causes a parallel flow in each systole.
- the second surface 27 of the arch section 2 runs in the region of its apex essentially in the plane of the lower wing part 7 in its closed state, so that when it closes, a free flow into the sinus and at each diastole a washout vortex is produced in it.
- FIG. 8B shows the cross section of the arch section 2 on the latter highest points or in the area of the connecting pieces and illustrates the projection 25 and the bearing surface 24.
- the connecting piece can be designed in such a way that the sealing line 10 of the wing pieces does not exceed them when opened and is therefore not exposed to the risk of ingrowth or interference with the body's own tissue, which further reduces the tendency to thrombosis.
Abstract
Prothèse de remplacement de valvules aortiques, avec un corps annulaire rigide en forme de siège de soupape, que l'on peut coudre chirurgicalement à la paroi aortique par l'ourlet textile placé sur son côté extérieur, et avec une partie de fermeture ayant la forme de volets d'aile disposés de manière pivotante sur le corps annulaire, qui libèrent ou bloquent en fonction de leur position le passage par l'ouverture intérieure du corps annulaire. Le corps annulaire (1) a la forme de trois segments d'arc (2) reliés entre eux à leurs extrémités (3), dont les plans sont disposés à angle aigu par rapport à la surface de base définie par les points de contact des segments d'arc. Dans chaque segment d'arc se trouve une aile pivotante (4, 20) avec un axe de pivot (5) situé dans la région des extrémités d'arc et traversant l'aile, dont la plus petite partie (7) recouvre le segment d'arc (2) et dont la plus grande partie (6) comporte deux bords intérieurs (8) s'étendant selon un angle obtus l'un par rapport à l'autre, leur configuration étant telle que, en position de blocage, chaque bord intérieur de chaque aile pivotante (4, 20) se rapproche du bord intérieur adjacent de l'aile pivotante voisine (4, 20).Aortic valve replacement prosthesis, with a rigid annular valve-seat-shaped body, which can be surgically sewn to the aortic wall through the textile hem placed on its outer side, and with a closing portion in the form of wing flaps pivotally arranged on the annular body, which release or block, depending on their position, the passage through the interior opening of the annular body. The annular body (1) has the shape of three arc segments (2) interconnected at their ends (3), the planes of which are arranged at an acute angle with respect to the base surface defined by the contact points of the arc segments. In each arc segment there is a pivoting wing (4, 20) with a pivot axis (5) located in the region of the arc ends and crossing the wing, the smallest part of which (7) covers the segment arc (2) and the largest part (6) of which has two interior edges (8) extending at an obtuse angle with respect to each other, their configuration being such that, in the locked position, each inner edge of each pivoting wing (4, 20) approaches the adjacent inner edge of the neighboring pivoting wing (4, 20).
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19843409005 DE3409005A1 (en) | 1984-03-09 | 1984-03-09 | PROSTHESIS FOR REPLACING AORTIC VALVES |
DE3409005 | 1984-03-09 |
Publications (2)
Publication Number | Publication Date |
---|---|
EP0173723A1 true EP0173723A1 (en) | 1986-03-12 |
EP0173723B1 EP0173723B1 (en) | 1989-10-11 |
Family
ID=6230234
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP85901357A Expired EP0173723B1 (en) | 1984-03-09 | 1985-03-08 | Prosthesis for replacing aortic valves |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP0173723B1 (en) |
DE (2) | DE3409005A1 (en) |
WO (1) | WO1985004094A1 (en) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3701702C1 (en) * | 1987-01-22 | 1988-07-14 | Braun Melsungen Ag | Heart valve prosthesis |
DE3701704C1 (en) * | 1987-01-22 | 1988-08-18 | Braun Melsungen Ag | Heart valve prosthesis |
DE3909495A1 (en) * | 1989-03-01 | 1990-09-13 | Anschuetz & Co Gmbh | Aortic valve prosthesis |
DK163338C (en) * | 1989-11-14 | 1992-07-13 | John Michael Hasenkam | HEART VALVE PROSTHESIS |
GB2281371A (en) * | 1993-08-26 | 1995-03-01 | Nasser Rasmi Hassan Rasmi | A prosthetic trileaflet heart valve |
FR2737655B1 (en) * | 1995-08-09 | 1997-12-26 | Didier Lapeyre | MECHANICAL VALVE PROSTHESIS WITH OPTIMIZED CLOSING MODE |
DE19532972C2 (en) * | 1995-09-07 | 1998-07-30 | Tricumed Medizintechnik Gmbh | Heart valve prosthesis |
DE19532973C1 (en) * | 1995-09-07 | 1996-11-07 | Tricumed Medizintechnik Gmbh | Prosthesis for replacing heart valve |
DE19627859C1 (en) * | 1996-07-11 | 1998-04-16 | Tricumed Medizintechnik Gmbh | Heart valve prosthesis |
US6395024B1 (en) * | 1997-05-20 | 2002-05-28 | Triflo Medical, Inc. | Mechanical heart valve |
DE19800498C1 (en) * | 1998-01-09 | 1999-08-26 | Sievers | Heart valve prosthesis |
RU2325874C2 (en) * | 2006-04-04 | 2008-06-10 | Александр Васильевич Самков | Cardiac valve prosthesis |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR1355214A (en) * | 1963-04-23 | 1964-03-13 | Inst Of Medical Sciences | Prosthetic valve for heart surgery |
DE2612810C3 (en) * | 1976-03-25 | 1981-02-12 | Bayer Ag, 5090 Leverkusen | Prosthetic heart valve |
FR2515506B1 (en) * | 1981-11-05 | 1985-12-20 | Murguet Robert | HEART VALVE PROSTHESIS |
US4406022A (en) * | 1981-11-16 | 1983-09-27 | Kathryn Roy | Prosthetic valve means for cardiovascular surgery |
-
1984
- 1984-03-09 DE DE19843409005 patent/DE3409005A1/en not_active Withdrawn
-
1985
- 1985-03-08 EP EP85901357A patent/EP0173723B1/en not_active Expired
- 1985-03-08 WO PCT/DE1985/000074 patent/WO1985004094A1/en active IP Right Grant
- 1985-03-08 DE DE8585901357T patent/DE3573527D1/en not_active Expired
Non-Patent Citations (1)
Title |
---|
See references of WO8504094A1 * |
Also Published As
Publication number | Publication date |
---|---|
DE3573527D1 (en) | 1989-11-16 |
EP0173723B1 (en) | 1989-10-11 |
WO1985004094A1 (en) | 1985-09-26 |
DE3409005A1 (en) | 1985-09-19 |
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